KHN: May 30, 2019. Thousands of patients were harmed and dozens killed by malfunctioning surgical staplers. Most of that information was hidden in an FDA database that was not publicly available, which NCHR criticizes as covering up information patients and physicians need to make informed decisions.
Read More »Tag: medical devices
NCHR Comment on Regulating Artificial Intelligence/Machine Learning-Based Software
June 3, 2019. Artificial Intelligence/Machine Learning (AI/ML)-based software device that incorporates special computer techniques (algorithms) capable of detecting relevant medical patterns from large amounts of data. These very sophisticated pattern recognition capabilities (AI/ML) have broad potential healthcare applications, including making recommendations to healthcare providers and patients about the diagnosis, prognosis, treatment, or prevention of disease.1 The complexity, scalability, and broad scope of these new technologies thus raise important issues regarding their safety and effectiveness as it pertains to patients’ health.
Read More »NCRH Testimony on Reclassification of Collagen-Based Hemostatic Devices
May 31, 2019. The safety and effectiveness of new devices needs to be established before they are approved. Approval of products without this evidence puts patients at risk for unnecessary harm. Adequate and well-controlled clinical trials are the best way to establish that the benefits outweigh the risks for patients needing collagen-based hemostatic devices.
Read More »NCHR Comments on Modernizing FDA’s 510(k) Program
May 22, 2019. The 510(k) pathway system is flawed, and should be replaced with pathways that require controlled clinical trials for all implanted devices and many other devices as well. Meanwhile, safety can be improved with our recommendations.
Read More »How the FDA Handles Recalls of Life-Saving Implants Could Put People at Risk, Patients Say
Nicole Carr, WSBTV; May 20, 2019 Geraldine Robinson is one of millions of Americans who use an implanted medical device to improve, and possibly extend her life. But when the implant was recalled years later, nobody told her. We help explain why.
Read More »